Author: Healio ophthalmology

FDA issues final rule on unique identification system for medical devices

FDA has announced its final rule for a unique device identification system that will help to locate medical devices and improve patient safety as well as assist the FDA in identifying problems and issue targeted recalls.“[Unique device identification] UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, stated in a press release.

Sleep apnea associated with risk of open-angle glaucoma 5 years after diagnosis

Obstructive sleep apnea was associated with an elevated risk of developing open-angle glaucoma within 5 years of sleep apnea diagnosis, according to a large cohort study.“Often, [obstructive sleep apnea] leads to severe hypoxemia and increases vascular resistance, which may influence the development of ganglion cell loss,” the study authors said. “Previous studies have demonstrated [obstructive sleep apnea] to be associated with several eye disorders, such as floppy eyelid syndrome, keratoconus, papilledema, optic neuropathy, filamentary or infectious keratitis, papillary conjunctivitis and glaucoma.”

Oral retinoid significantly improves function in eyes with retinitis pigmentosa

Oral treatment with 9-cis beta-carotene markedly improved retinal function in patients with retinitis pigmentosa, according to a study.The randomized clinical trial included 29 patients who underwent a 90-day regimen of four daily capsules of 300-mg 9-cis β-carotene-rich alga D bardawil (β-carotene powder, approximately 20 mg) or a placebo comprising starch powder.

Anterior uveitis present in 18.5% of Ibero-American SpA patients

Anterior uveitis was present in nearly 20% of a large cohort of patients with spondylarthritis in Ibero-American countries and was positively associated with axial involvement and HLA-B27, according to study results.Researchers investigated clinical and demographic variables and disease indices of 2,012 patients with spondylarthritis (SpA) from 85 centers across 10 Ibero-American countries. Fisher’s exact and chi-squared tests were used to compare categorical variables, while ANOVA and Kruskal-Wallis tests compared continuous variables.

Cosmetic eye whitening with mitomycin C poses high complication, retreatment rates

Regional cosmetic conjunctivectomy with postoperative topical mitomycin C with or without bevacizumab injection had high complication and retreatment rates, according to a study.“We recommend longer follow-up of this population that is at risk for future complications and continued search for a better treatment of chronic conjunctival hyperemia,” the study authors said.

Nutritional supplements drive significant improvement in dry eye symptoms, study finds

Postmenopausal patients with moderate-to-severe keratoconjunctivitis sicca may benefit from supplementats with gamma-linolenic acid and omega-3 polyunsaturated fatty acids for treatment of tear dysfunction, according to a study.“Nutritional supplementation with black currant seed oil [gamma-linolenic acid] and fish oil [omega-3 polyunsaturated fatty acids] should be considered in the treatment of tear dysfunction to decrease irritation symptoms and prevent exacerbations in ocular surface inflammation and corneal epithelial disease,” the study authors said.

Phaco-laser trabeculotomy markedly reduces IOP, medication use up to 12 months

Phacoemulsification with excimer laser trabeculotomy reduced IOP and the need for IOP-reducing medications in patients with glaucoma or ocular hypertension, according to a study.“IOP remained significantly reduced from baseline 12 months after phaco-ELT [excimer laser trabeculotomy] regardless of preoperative IOP levels, with no major complications. The IOP reduction remained constant over the entire follow-up,” the study authors said.

Study links refractive error to ciliary muscle thickness in children

Posterior ciliary muscle fibers were thicker in children with myopia, while the apical region of the ciliary muscle was thicker in hyperopes, according to a study.“This is likely the first evidence suggesting that accommodative workload is associated with a specific region of the muscle, which is largely comprised of circular and some radial fibers,” the study authors said.

Aflibercept reduces subfoveal fluid in eyes with persistent exudative AMD

Aflibercept yielded positive anatomic results in cases of exudative age-related macular degeneration that were resistant to ranibizumab or bevacizumab, according to a study.“Visual acuity did not improve. Aflibercept may be beneficial anatomically in cases of exudative AMD treated with persistent fluid on ranibizumab and/or bevacizumab,” the study authors said.

BLOG: Gonioprism simplifies iStent implantation

About a year ago, my partners and I began using the iStent trabecular bypass device shortly after its approval by the U.S. Food and Drug Administration.This wonderful device has changed our thinking about cataract surgery and the glaucoma patient, allowing us to lower pressure in the vast majority of cases with a fairly simple device whose implantation accompanies cataract surgery nicely. I have used it in 25 to 30 patients, including two undergoing Descemet’s stripping endothelial keratoplasty surgery simultaneously with cataract extraction.